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Azure 19.328

by Terrats Medical SL

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K222288

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08435750416818 UDI-DI Date21 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222288 Date27 Oct 2022DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Azure
Generic name
Dental prosthesis/implant abutment screw
Model / Ref / Catalog
19.328, ARNAC-STRXTI43
Primary DI / UDI-DI
08435750416818
510(k) Number
FDA product code
NHA
GMDN term
Dental prosthesis/implant abutment screw
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental prosthesis/implant abutment screw

Cleared under the same submission (K222288)

Show all (12)

Other devices from Terrats Medical, S.L.

See all devices from Terrats Medical, S.L. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (10)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No